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A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03214757
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Amar, Assiut University

Tracking Information
First Submitted Date July 7, 2017
First Posted Date July 12, 2017
Last Update Posted Date January 10, 2018
Estimated Study Start Date February 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2017)
Heart failure [ Time Frame: four months duration after start of the study ]
Through clinical manifestations of heart of heart failure and echocardiographic assesment of ventricular function
Original Primary Outcome Measures
 (submitted: July 9, 2017)
Heart failure [ Time Frame: three months duration after start of the study ]
Through clinical manifestations of heart of heart failure and echocardiographic assesment of ventricular function
Change History Complete list of historical versions of study NCT03214757 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2017)
Quality of Well-Being Scale [ Time Frame: three months duration after start of the study ]
To measure health related quality of life, to monitor the health of populations over time, or to evaluate the efficacy and effectiveness of clinical therapies of practices using a preference weighted self administered measure.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy
Official Title A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy
Brief Summary

Dilated cardiomyopathy is a heart muscle disorder characterized by systolic dysfunction and dilation of the left or both ventricles.Dilated cardiomyopathy can develop in people of any age or ethnicity, although it is more common in male than female persons occurring at a ratio of about three to one in male to female persons.

Dilated cardiomyopathy is the predominant cause of cardiomyopathy in pediatric populations. Annual incidence in pediatric populations has been reported to be much lower than one to one hundred seventy thousand in the United States and one to one hundred forty thousand in Australia.

Although pediatric dilated cardiomyopathy has a lower annual incidence than adult dilated cardiomyopathy, the outcome for pediatric dilated cardiomyopathy patients is particularly severe.

Dilated cardiomyopathy is the most frequent cause of heart transplantation in pediatric patients. Data from international pediatric dilated cardiomyopathy registries indicate that the rates of death or heart transplantation over one and five year periods were thirty one percent and forty six percent, respectively.

Onset of dilated cardiomyopathy is usually insidious but may be acute in as many at twenty five percent of patients. Approximately fifty percent of patients with dilated cardiomyopathy have a history of preceding viral illness.

Detailed Description

The clinical diagnosis of dilated cardiomyopathy is made from history, physical examination, and noninvasive testing. The initial clinical manifestations of dilated heart failure are generally those of respiratory distress secondary to congestion of the pulmonary and systemic venous circulations.

Pallor, irritability, diaphoresis, tachypnea, easy fatigability are characteristics.

Failure to grow may also occur. In older patients, a history of orthopnea, nocturnal cough, and dyspnea provoked by minimal activity can be elicited and generally precede evidence of systemic venous congestion. In rapidly progressive disease, dominant symptoms are often abdominal distention, right upper quadrant pain, and nausea. Less often, initial symptoms in childhood include arrhythmias, syncope, neurologic problems (seizures or delayed development), vomiting, abdominal distention, or fever.

Although as many as fifty percent of children with cardiomyopathy and heart failure give a history of a nonspecific febrile illness within three months of presentation, no evidence of myocarditis can usually be found on biopsy.'Physical signs vary with the stage of the disease.

Signs of congestive heart failure are frequent, and include tachypnea,tachycardia, diaphoresis, hepatomegaly, pallor, and, in advanced cases, hypotension and shock.

Failure to thrive may be present if, heart failure has been long standing. Patients are generally not cyanotic. Wheezing may be heard; however, rales are infrequent, especially in infants.

Neck vein distension is common, the external jugular crest reflecting mean right atrial pressure, the internal jugular exhibiting a prominent V wave indicative of tricuspid regurgitation.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All infants and children with dilated cardiomyopathy who are diagnosed clinically and by echocardiography attending cardiology outpatient clinic at Assiut University Children Hospital.
Condition Pediatric Dilated Cardiomyopathy
Intervention Other: treatment of anemia.
drug treatment of anemia.
Study Groups/Cohorts
  • group with dilated cardiomyopathy without anemia
  • group with dilated cardiomyopathy with anemia
    Intervention: Other: treatment of anemia.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 8, 2018)
40
Original Estimated Enrollment
 (submitted: July 9, 2017)
100
Estimated Study Completion Date December 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All infants and children with dilated cardiomyopathy who are diagnosed clinically and by echocardiography attending cardiology outpatient clinic at Assiut University Children Hospital will be included.

Exclusion Criteria:

  • Infants age less than two months.
  • Infants with hemolytic anemias.
  • Patients with congestive heart failure due to congenital heart disease.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nagwa Ali Mohammed, MD 0201096260950 Namma65@yahoo.com
Contact: Osama Mahmoud El-Asheer, MD 0201001348864 Asheer1970@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03214757
Other Study ID Numbers NA_0000XXX
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohamed Ahmed Amar, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date January 2018